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Clinical Research Manager

Job Description

Requisition ID: 5040181019

The NeuWave
platform in The Ethicon Franchise, a member of Johnson & Johnson's
Family of Companies, is recruiting for a Clinical Research Manager located in Somerville, NJ and may require
up to 25% of domestic and international travel.

From
creating the first sutures, to revolutionizing surgery with minimally invasive
procedures, Ethicon has made significant contributions to surgery for more than
60 years. Our continuing dedication to Shape the Future of Surgery is built on
our commitment to help address the world’s most pressing health care issues,
and improve and save more lives. Through Ethicon’s surgical technologies and
solutions including sutures, staplers, energy devices, trocars and hemostats
and our commitment to treating serious medical conditions like obesity and
cancer worldwide, we deliver innovation to make a life-changing impact.

Thriving
on a diverse company culture, celebrating the uniqueness of our employees and committed
to inclusion. Proud to be an equal opportunity employer.

Operating on behalf of the NeuWave Preclinical,
Clinical and Medical Affairs (PCM), Group, this individual will have strong
scientific expertise to provide insights and strategic direction to develop
innovative evidence generation and dissemination strategies (EGS / EDS) for New
Product Development and Life-Cycle Management (NPD and LCM) projects.

Responsible for delivery of assigned clinical projects,
through effective partnership with the Clinical Operations and BSDM teams, to
enable optimized engagement leading to delivery of clinical project commitments
(delivery on time, within budget and in compliance with regulations and SOP);

Ensure input and strong alignment from key regional Medical
Device Clinical R&D leads and other strategically important
countries/regions in the development of the EGS / EDS;

Lead in study design to develop appropriate clinical
trials to meet the NPD / LCM needs;

Lead in appropriate interpretation and dissemination
of all evidence generated, based on EDS, including Clinical Study Reports,
abstracts, manuscripts, CERs etc

Contribute in clinical scientific discussions with
regulatory agencies / notified bodies to drive support of the clinical and
regulatory strategy, including proposed clinical investigations; review process
of clinical evidence generated for marketing authorization, line extensions,
etc, including during sponsor regulatory inspections;

Partner with internal stakeholders to ensure accurate
dissemination of clinical data/evidence in value briefs and technical summaries
for market access and reimbursement

Be a subject matter expert in the development of
clinical evidence in the cancer / interventional oncology therapeutic areas of
interest

Functional and Technical Competencies:

Thorough
understanding of clinical research science and processes along with a broad and
extensive understanding of product development processes, team dynamics,
related healthcare market environment, clinical trends, and global clinical
trial regulations;

Ability to
provide strategic and scientific clinical research input across NPD and LCM projects,
including complex and / or transformational projects;

Proven track
record in delivering clinical programs within clinical / surgical research
setting, on time, within budget and in compliance to SOPs and regulations;

Ability to lead
teams to deliver critical milestones, including complex projects;

Ability to
collaborate across different functional areas within CR&D to ensure
alignment with governance processes (assigning roles and responsibilities,
setting priorities, managing deliverables, etc). and to meet business
objectives;

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity Posters

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please complete the form below. If you’d like to view a copy of the company’s affirmative action plan, please complete this form.

This site is governed solely by applicable U.S. laws and governmental regulations. Please see our Privacy Policy. Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is subject to the terms of our Legal Notice. You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Johnson & Johnson Services, Inc. Contact Us with any questions or search this site for more information.